# K981590: Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 10, 1998 after 37 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903430 (1990). 1 ancestor in all.
8 later devices descend from it; 5 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903430: Liquichek CK/LD Isoenzyme Control; Levels 1 and 2, Bio-Rad (1990) Summary page 1.

## Most influential descendants
- K021384: Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444 (2002), 2 descendants of its own
- K012999: Triage Tox Drug Screen Controls, Catalog #94001 (2001), 2 descendants of its own
- K050037: Triage Tox Drug Screen Controls (2005), 1 descendant of its own
- K033404: Liquichek Urine Toxicology Control (Confirmatory Series) (2003), 1 descendant of its own
- K060788: Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414 (2006), 0 descendants of its own

## Indications for use
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

Source page: https://510kreport.com/device/K981590
Methodology: https://510kreport.com/methodology